1. Field
This disclosure relates to medical devices having a hemostasis component. More particularly, an expandable sleeve on the proximate end of a catheter is effective to stanch blood flow.
2. Description of the Related Art
Patients with end stage renal disease (ESRD) often require long term hemodialysis which is performed using a surgically placed AV fistula, a connection between a vein and an artery. While a patient is waiting for fistula surgery, or if the fistula is not working properly, dialysis can be performed via a tunneled catheter, also referred to as a PERMCATH® catheter (Trademark of Covidien AG Corporation, Am Rheinfall, Switzerland).
The catheter is a large bore catheter (15-16 French size) which is tunneled from the subcutaneous tissues of the chest wall, and then inserted into the internal jugular vein (or other large vein) using interventional radiology techniques. Exemplary is the Quinton™ Permcath™ Dual Lumen Catheter (trademark of Covidien, Mansfield, Mass.) that provides blood flow rates of 350-400 mL/min and maintains low arterial and venous pressures. The catheter is made of a soft, silicone material and is designed with a staggered tip to provide a 2.5 cm separation between the arterial lumen and venous tip. The catheter is provided in a variety of insertion lengths to accommodate different patient anatomies and physician insertion practices.
The process of tunneling the catheter involves attaching the catheter to a long metal tunneling device which bores through the subcutaneous tissues. The tunneling process is traumatic as small blood vessels in the subcutaneous tissues are torn by the tunneling device causing bleeding out of the tunnel track. This is even more problematic in patients with ESRD, as their blood does not clot as well due to problems with platelet function, which is necessary to adequately clot the blood. Physicians are often called to deal with bleeding from the permcath site. Medical intervention can be time consuming, as it requires anything from holding pressure to putting in sutures in order to stop the bleeding. Sutures must be removed at some point because skin damage can occur if the sutures remain for an extended period of time.
Devices for promoting hemostasis in a blood vessel puncture are disclosed in U.S. Pat. No. 5,904,147 to Conlan et al. and in U.S. Pat. No. 6,071,300 to Brenneman et al. Both U.S. Pat. No. 5,904,147 and U.S. Pat. No. 6,071,300 are incorporated by reference herein in their entireties.
Accordingly, there remains a need for an improved tunneling catheter for hemodialysis and others functions that has an improved hemostasis component.